Phase 3
Completed N=40
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
Source: ClinicalTrials.gov NCT01814137 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — 0.05; -0.49 percentage of glycosylated haemoglobin
Summary
This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
0.05; -0.49 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
33; 45 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes |
54; 95 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes |
13; 12 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-0.80; -2.57 | — |
Eligibility Criteria
Inclusion Criteria
- HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory
Exclusion Criteria
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
- Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
- Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
Data sourced from ClinicalTrials.gov (NCT01814137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.